The present invention relates to methods and apparatus for treatment of diseases and pathologies of the bladder, urinary sphincter or other sphincters.
Urinary incontinence affects 13 million American women. Incontinence is the involuntary loss of urine which is sufficient to impact the life style of the patient. Among community dwelling older adults, the reported incidence of incontinence is 3-25% with 15-36% complaining of severe incontinence. Further, these numbers are anticipated to rise substantially as the population ages. It is a major cause of deterioration of the quality of life and loss of independence. In fact, incontinence has been implicated as a major factor influencing individuals (and their families) to opt for admission into a nursing home, as they are no longer able to provide adequate care at home.
The predominant type of incontinence in women is genuine stress urinary incontinence (GSUI, which is implicated in 75-80% of cases). It is usually caused by a weakening of the pelvic floor muscles which is often associated with childbearing. This results in the displacement of the proximal urethra outside of the abdominal pressure zone. Therefore, an increase in intra-abdominal pressure is transmitted to the bladder but not to the urethra. The result is an involuntary loss of urine with cough, sneeze, or even with acts as simple as walking. Not surprisingly, a considerable amount of work has gone into development of a solution for this problem. Several treatments have been developed which aim to lift the bladder neck back into the abdomen. These procedures include the Burch urethropexy, the Kelly application, and the Marshall-Marchetti-Krantz suspension. The unfortunate downside to each of these is that they require surgical intervention and its associated morbidity. A minimally invasive, non-surgical therapy would be a significant improvement in the treatment of these patients.
One preferred embodiment of the present invention relates to an implantable apparatus including a plug member having a lumen and a valve adapted to open and close the lumen in response to a signal. The apparatus also includes at least one sensor and a controller adapted to control the valve.
In one aspect of certain Embodiments, the controller is programmable to open the valve to permit the flow of urine under at least one mode of operation selected from a predetermined time interval operation a sensor operation, and a manual actuation operation.
Another embodiment relates to a flow control apparatus for insertion into a patient""s body, including an intravesicular pressure transducer and a polyelectrolytic hydrogel.
Another embodiment relates to a sphincter including an inner ring and an outer ring spaced a distance from the inner ring. The sphincter includes a plurality of hydrogel fibers extending between the inner ring and the outer ring.
Another embodiment relates to a sphincter having an inner tube and an outer tube surrounding the inner tube. The sphincter includes at least one hydrogel fiber wrapped around the inner tube. The hydrogel fiber is designed to contract in response to a signal and close the inner tube.
Yet another embodiment relates to an apparatus for controlling urine flow in a patient, including valve means for controlling the flow of urine. The valve means is implantable in the patient""s body. The apparatus also includes a control means external to the patient""s body for supplying a signal to control the valve means.
Another embodiment relates to an apparatus for controlling the flow of a substance in a patient""s body. The apparatus includes an implantable valve placed at a position along the route that the substance flows through the body, and a controller for opening and closing the valve in response to an input provided by the patient.
Other embodiments relate to methods including a method to control the flow of urine in a patient, including implanting a plug device including an integral controller, a valve, and at least one sensor into the patient. An increase in an intravesicular pressure is sensed in at least one of the bladder and urethra, and a signal is supplied to the controller in response to the pressure increase. The valve is opened when the pressure reaches a first predetermined amount and closed when the pressure decreases to a second predetermined amount.
Still another embodiment relates to a method for controlling the urinary flow of a patient including positioning a valve in the patient in a location selected from the group of the urethra and the bladder. An electrical signal to a hydrogel component may actuate the valve and control the flow of urine.
Still another embodiment relates to a method for controlling the opening and closing of an implanted valve in a patient, including providing an implanted first control device in the patient to open and close the valve. A second control device is provided outside of the patient, and the first control device is programmed by sending a signal from the second control device to the first control device.